Analysis on the Health of Newborns in Three Hospitals, 2008-2024

NCT06758622 | Active Not Recruiting

• 1 other identifier: CEISH-HGDC-2024-007
• Study Type: observational
• Target: 40,000
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this observational study is to analyze the factors associated with neonatal morbidity and mortality in three hospitals in Quito, Ecuador, from January 2022 to December 2023. The primary question to be addressed is: What perinatal factors are associated with neonatal morbidity and mortality in neonates admitted to HGOIA, HGDC, and HGONA hospitals? The participants will be neonates whose complete medical records are registered in the Perinatal Information System (SIP) and the Maternal-Perinatal Clinical Record (HCMP) databases during the study period. Data will be retrospectively collected from the mentioned databases, evaluating variables such as birth weight, gestational age, congenital anomalies, neonatal complications, and maternal factors such as age and medical conditions. The analysis will include prevalence calculations, variable associations through logistic regression, and the development of neonatal growth curves. Statistical software such as R will be used for data analysis, and the results will be compared to national and international standards.

Conditions

Neonatal Morbidity and Mortality; Intrauterine Growth Disorders (IUGR and Macrosomia); Prematurity Complications; Neonatal Infections

Keywords

Neonatal Mortality; Neonatal Morbidity; Infant, Low Birth Weight

Outcome Measures

Primary Outcomes (1)

• Neonatal Morbidity and Mortality Rate

  Definition: Proportion of neonates experiencing morbidity (severe diseases or complications) or mortality within the first 28 days of life. Method of Measurement: Calculation of rates and proportions using Perinatal Information System and Maternal perinatal medical records. Unit of Measure: Percentage (%) per 1000 live births. Time Frame: From birth to 28 days of life.

  14 years

Secondary Outcomes (3)

• Prevalence of Intrauterine Growth Disorders (Low Birth Weight and Macrosomia)

  14 years

• Incidence of Prematurity-Related Complications

  14 years

• Comparison of Indicators Across Hospitals

  14 years

Study Arms (1)

Definition: This group includes neonates admitted to HGOIA, HGDC, and HGONA between January 2008 and

Eligibility Criteria

• Age: 0 Days - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of neonates born between January 2022 and December 2023 at three hospitals in Quito, Ecuador: Hospital Gineco Obstétrico Isidro Ayora, Hospital General Docente de Calderón, and Hospital Gineco Obstétrico Pediátrico de Nueva Aurora Luz Elena Arismendi. These neonates must have complete perinatal medical records documented in the Perinatal Information System or the Maternal-Perinatal Clinical Record. The population includes neonates with varying birth weights, gestational ages, and neonatal complications, as well as their associated maternal conditions, such as age, comorbidities, and pregnancy outcomes. The study focuses on analyzing the prevalence of morbidity and mortality, growth disorders (low birth weight and macrosomia), prematurity-related complications, and adherence to neonatal care interventions like the Kangaroo Mother Care program and Human Milk Bank services.

You may qualify if:

• Neonates registered in the Perinatal Information System or the Maternal-Perinatal Clinical Record during the study period (January 2022 to December 2023).
• Neonates born in the participating hospitals: Hospital Gineco Obstétrico Isidro Ayora, Hospital General Docente de Calderón, and Hospital Gineco Obstétrico Pediátrico de Nueva Aurora Luz Elena Arismendi.
• Perinatal medical records with complete data, including information on birth weight, gestational age, neonatal complications, and maternal conditions.

You may not qualify if:

• Neonates with incomplete or inconsistent clinical records in the Perinatal Information System or the Maternal-Perinatal Clinical Record.
• Perinatal medical records missing key information, such as discharge diagnoses, gestational age, or birth weight.
• Neonates born outside the participating institutions during the study period.

Sponsors & Collaborators

• HOSPITAL GINECO OBSTETRICO ISIDRO AYORA: lead
• Universidad Central del Ecuador: collaborator

Study Sites (1)

Hospital Gineco Obstétrico Isidro Ayora

Quito, Pichincha, 170601, Ecuador

Location

Related Publications (1)

• Rosero-Quintana MD, Vasco-Morales S, Benalcazar-Sanmartin K, Salazar-Congacha LP, Toapanta-Pinta PC. Frequency of episiotomy practice in an institution in Quito, Ecuador 2009-2022. Rev Colomb Obstet Ginecol. 2024 Jul 9;75(2):4216. doi: 10.18597/rcog.4216. English, Spanish.

  PMID: 39470265 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Fetal Growth Retardation

Condition Hierarchy (Ancestors)

Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Elina Yanez Valencia, Neonatologa

  Hospital Docente de Calderon

  STUDY DIRECTOR

• Monica Diaz Torres, Neonatologa

  Hospital Gineco Obstétrico Pediátrico de Nueva Aurora Luz Elena Arismendi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MEDICO PEDIATRA

Study Record Dates

• First Submitted: December 20, 2024
• First Posted: January 6, 2025
• Study Start: November 12, 2024
• Primary Completion: November 12, 2025
• Study Completion: December 10, 2025
• Last Updated: January 6, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

EC (1)